Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
35 participants
INTERVENTIONAL
2022-05-26
2023-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Abilitech Assist
The Abilitech™ Assist device is a passively powered orthotic device designed to support and assist the arms of patients with neuromuscular weakness for activities of daily living.
Abilitech Assist
The Abilitech™ Assist is an externally worn device supported by a body frame, which is designed to support and assist the arms in activities of daily living (ADL's). The Abilitech Assist is comprised of three parts: a modular body vest that adjusts to accommodate different body sizes, a single arm orthosis that attaches to the body vest, and an external power pack and controller for tensioning the arm's internal springs to adjust the arm's level of assist. The device augments a user's native arm function to provide lift assistance. Software customizes the spring tension for the level of assist required. The user can turn the system ON/OFF and toggle and adjust the level of assist (e.g., low, medium or high assist) using a pushbutton controller.
Interventions
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Abilitech Assist
The Abilitech™ Assist is an externally worn device supported by a body frame, which is designed to support and assist the arms in activities of daily living (ADL's). The Abilitech Assist is comprised of three parts: a modular body vest that adjusts to accommodate different body sizes, a single arm orthosis that attaches to the body vest, and an external power pack and controller for tensioning the arm's internal springs to adjust the arm's level of assist. The device augments a user's native arm function to provide lift assistance. Software customizes the spring tension for the level of assist required. The user can turn the system ON/OFF and toggle and adjust the level of assist (e.g., low, medium or high assist) using a pushbutton controller.
Eligibility Criteria
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Inclusion Criteria
2. MMT score of 1-3 in the elbow, wrist and hand; and a MMT score of 2-3 in the shoulder of at least one of the subject's arms
3. Ability of subject to raise their forearm off of their lap or laptray
4. Willingness to comply and participate with the study protocol and attend the study sessions
5. Ability to communicate verbally and respond to questions and commands
6. Ability to provide informed consent
7. Selected for participation based on investigator discretion
Exclusion Criteria
2. Open wounds or chronic pressure sores on upper extremities, neck, back or torso
3. Significantly unstable upper extremity joints
4. Unhealed bone fractures in the upper extremities
5. Active rotator cuff tear, grade 2 or 3
6. Surgical fixations limiting full passive range of motion
7. Uncontrolled upper-limb spasticity that significantly limits normal range of motion
8. Uncontrollable pain in the neck, shoulders or upper limbs
9. Ability to fully raise both hands simultaneously above their head with ease as defined by the investigator
10. Lack passive shoulder abduction of 120 degrees
11. Lack 90 degrees of passive elbow extension
12. Unable to follow instructions
13. Exhibit significant behavioral problems
14. Inability to provide consent
10 Years
ALL
No
Sponsors
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Richard M. Schulze Family Foundation
UNKNOWN
AbiliTech Medical Inc.
INDUSTRY
Responsible Party
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Locations
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Gillette Children's
Saint Paul, Minnesota, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Schulze
Identifier Type: -
Identifier Source: org_study_id
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